BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1220381 · Received October 31, 2008

    Report

    Report Number
    2028159-2008-00398
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM WITH NO PROBLEMS FOUND. THE SYSTEM AND HANDPIECE WERE PRIMED AND TUNED WITH NO OCCLUSION ADVISORY DISPLAYED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO ECRI HEALTH DEVICES, HAZARD UPDATE: SCLERAL AND CORNEAL BURNS DURING PHACOEMULSIFICATION, NOVEMBER 1996, VOL. 25, NO. 11: 426-431, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MANUFACTURING EQUIPMENT. A LETTER AND COPY OF THIS INDUSTRY ARTICLE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE FACILITY BIOMEDICAL TECHNICIAN REPORTED AN OCCLUSION ADVISORY DISPLAYED AND A CORNEAL BURN OCCURRED. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, AND PATIENT STATUS WITH NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI